A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: QA Associate Manager - 1
Job Description:
Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP in TRD.
Support Novartis drug development, drug production and/or life cycle management by providing GMP exper-tise.
Support timely release of GMP documents, batches and follow-up activities.
1. Perform the role of local document manager for quality relevant electronic systems (e.g. AQWA, TEDI, ESOPS and Learning Management System).
2. Support the line unit function in the use of GMP relevant IT tools and processes. Contribute to the implementation of new tools as needed.
3. File and archive documents owned by QA (e.g. Authorized and/or implemented QM/QD, train-ing plan and training records, audit reports, etc).
4. Support the Key Quality Indicator reporting and follow up timely closure of CAPA actions from internal and external audit.
5. Perform review of GMP relevant documents for compliance with SOPs across several custom-er groups (e.g. TEDI documents, SOPs, analytical raw data, qualification documents, etc).
6. Clarify simple deficiencies in GMP documents with the line unit experts in own responsibility.
7. Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up.
8. Write and complete quality relevant documents in own area of responsibility (e.g. SOPs).
9. Participate in knowledge exchange in TRD.
Minimum requirements:
Should posses a bachelor degree in laboratory, IT, pharmaceutical or relevant discipline.
GMP working experience is a plus.
Should be fluent in English (adequate knowledge oral and good in written) in addition to the following:
1). Minimum 5+ years of relevant experience in a corresponding line unit function (e.g. laboratory, IT, project management or pharmaceutical development and/or Quality Assurance and Quality Control). Good organizational skills and pay attention to details.
2). Good communication skills to address quality and logistic related questions within QA and with the line unit experts
3). Knowledge and flexibility to work with relevant IT systems and MS Office tools such Excel and Power Points.
4) Be a self motivated and work independently with minimum supervision.
Additional Information:
Experience: 5 years
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Business Unit: Pharma - Global Development
Job Type: Full Time
Employment Type: Permanent
Job ID: 118188BR
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